ABSTRACT

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa

chapter |3 pages

Part 803 Medical Device Reporting

chapter |20 pages

Part 820 Quality System Regulation

chapter |14 pages

Military Specification

chapter |32 pages

Quality Management Systems—Requirements